RAPS Western Canada Chapter’s Post

Elated to have completed the SBIA Regulatory Education for Industry (REdI) Conference hosted by the Center for Devices and Radiological Health (CDRH). This invaluable experience has significantly enhanced my understanding of regulatory processes and device innovation. I look forward to applying this knowledge to advance healthcare technology. #MedicalDevices #RegulatoryAffairs #ProfessionalDevelopment #FDA

I successfully completed and received a course completion certificate from Health Canada! 🎉 Course name: "𝙐𝙣𝙙𝙚𝙧𝙨𝙩𝙖𝙣𝙙𝙞𝙣𝙜 𝙃𝙤𝙬 𝙈𝙚𝙙𝙞𝙘𝙖𝙡 𝘿𝙚𝙫𝙞𝙘𝙚𝙨 𝙖𝙧𝙚 𝙍𝙚𝙜𝙪𝙡𝙖𝙩𝙚𝙙 𝙞𝙣 𝘾𝙖𝙣𝙖𝙙𝙖"! ➡️ 𝐊𝐞𝐲 𝐓𝐚𝐤𝐞𝐚𝐰𝐚𝐲/𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠𝐬 𝐟𝐫𝐨𝐦 𝐭𝐡𝐢𝐬 𝐂𝐨𝐮𝐫𝐬𝐞 𝐚𝐫𝐞: ▶️ Ministry of Health - functions & divisions Act, Legislations and Guidance's in context of Medical Devices in Canada ▶️ Classification of Medical Devices which are not In-vitro Diagnostic Devices, i.e. Non-IVD Medical Devices as per MDR, Canada. ▶️ Classification of In-vitro Diagnostic Devices (IVDD) as per MDR, Canada. ▶️ Types of Licensing Applications and Licensing Requirements ▶️ Licensing Stages #certificateofcompletion #coursecompletion #medicaldevices #mdr #canada #healthcanada #medicaldeviceindustry #freecourses #medtech #learning #constantlearning #tataelxsi #medicaldevicemanufacturing #regulatoryaffairs

Getting ready for 2025: Joint Clinical Assessment by HTAs at European level will become reality soon and the interface with the regulatory processes are being established. It was a true pleasure to co-chair with Niklas Hedberg today’s HTA Townhall at DIA Europe in Brussels and to discuss with the various actors these exciting and ground-breaking developments. The commitment by all in the panel - #policy makers, #regulatory and market #access colleagues from industry, #HTA colleagues, #regulators and #patient representatives - is clearly there: we need to collectively establish the most suitable practices for this interface. Asking the (mainly industry) audience for their priorities, bridging internal processes and looking at evidence needs also in the global context were highest ranking. The clock is ticking so planning (eg portfolio reviews), internal alignment as well as using opportunities to discuss evidence plans (such as the interim framework for parallel EMA / HTA body advice) were certainly take-home messages from the discussion. And Isabelle Stoeckert sharing experience with preparatory steps was certainly insightful for all participants. Thank you to the panelists and the audience for very engaging discussions!

**MY CARAQA BLOG - Lesson 2** Olympic Games 🏅 takeaways for this week 1) 🥉 Drugs and medical technologies represent less than 1/4 of total healthcare expenditure. Hospital operations (in & outpatient care & rehab, admin, etc.) accounts for the remaining 3/4. ➡️ Optimizing hospital management is the key to preserve medical innovation. #Innovation 2) 🏈 ∫(Unmet Need / Marketing / Regulatory / Reimbursement) = Strategy 3) 🚧 1st hurdle to market introduction for the Medical Devices in the EU: CE Mark. 🚧🚧 2nd gigantic hurdle: Reimbursement -selling is not enough- and funding is country-specific. 4)🏃♀️ 🏃♂️ Clinical Studies are needed to get the CE Mark and Cost-effectiveness ones to unlock reimbursement by the health technology assessment (HTA) bodies. ➡️ Market Access Plan is a relay race, so start asap! #Marketaccess #Clinicalevidence #Costeffectiveness 5) Each country has different habits and customs for the approval of the HTA dossiers: trust-based principle in with reimbursement at launch in CH; in DE initial conditional reimbursement and full reimbursement after two years and of real-world evidence assessment. In FR the reimbursement needs massive evidence and can take much longer. ➡️Let’s build a reimbursement roadmap! #Reimbursement Good news: HTA bodies welcome cumulative evidence from one another and from 2025 a new framework including joint clinical assessments and scientific consultations will apply in the EU*. #HTAR (*https://lnkd.in/efaKQ9fM)

Regulatory convergence for medical products keeps us safe, enhances access to life-saving and life-enhancing products, and reduces duplication while saving limited public health resources for pressing needs.   Access Partnership proudly collaborated with regulatory leaders and governments in Lima, Peru to formalize the role of the Regulatory Harmonization Steering Committee – a body convening industry, regulators, and academia across 21 economies – under the auspices of the APEC - Asia-Pacific Economic Cooperation.   Now fully reconstituted, the RHSC is poised accelerate: ⚕ Adoption of internationally recognized standards such as ICH and IMDRF 🎒 Training for thousands of regulators and industry members through a network of Centers of Excellence for Regulatory Sciences such as those at Northeastern University, University of Southern California, Peking University, Duke-NUS Medical School and beyond ⚡ Cultivation of political will for convergence and reliance among regulatory policymakers   As we continue our journey, recognizing that regulatory convergence is an ongoing effort, we are eager to build upon the achievements of the past 15 years and incubate new ideas in 2024.   A heartfelt thank you 🙏 to all who have supported the RHSC's mission, contributing to the advancement of public health worldwide.   #APEC #RHSC #RegulatoryHarmonization Janet Vessotskie Amanda Roache Anne Blatchford Michelle Limoli Deanne de Lima Fa-Shen Vincent Wang Matt Murray Kent Shigetomi Ryan MacFarlane Eric Obscherning 🧬 Sannie SF Chong Rominder (Romi) Singh WASSIM NASHABEH Dinesh KHOKAL, PhD Nancy Schwalje Travis Jared Auclair John Lim Silke Vogel Mike Schmitz Michelle McConnell Erika Elvander Han Ju Koo Miranda Smith Clara Davis Susan C. Kim https://lnkd.in/eJbM-pUS

🗃️Preparing for the introduction of Joint Clinical Assessment #JCA which will be implemented from January 2025 is about much more than just a different HTA dossier. 🌍The elevation of health technology appraisal to a European level, and the interconnectivity with national processes to subsequently determine value will require new ways of thinking, decision making and integrated planning within organisations. 🫱🏼🫲🏼Close alignment between the European Medicines Agency (EMA) and the Coordinating Group for JCA in terms of notification, timing and “scientific exchange” mean a greater attention to cross functional alignment internally. ❓The anticipation and prediction of multiple PICOs (policy questions examining population, intervention, comparator and outcomes) across the member states and early preparation in terms of evidence synthesis and planning will be central to readiness, particularly given the tight timeframes associated with the process once initiated. 🔬In recognition of this, we have developed the JCA Lab (more to follow soon) which includes a comprehensive JCA Readiness Assessment tool to help companies plan the preparatory shifts and rewiring needed to ensure a successful implementation of European HTA. 🧑🏽🤝🧑Figuring out where the work gets done, how decisions get made, and the impact of EU HTA on each department, function and affiliate is key to effective implementation. Coupled with our proprietary approach to PICO Prediction (www.picopredict.com) the JCA lab brings a structured, objective way of planning and tracking JCA Readiness. 🎆Are you JCA Ready? #teamdecisive can help you get there. Please reach out to Esther Nzenza esther.nzenza@decisiveconsulting.co.uk or Kevin Asher kevin.asher@decisiveconsulting.co.uk for an exploratory chat. #hta #jca #rebelthinkers #jcaready #heor #marketaccess

Are you struggling to navigate the SaMD Registration Requirements for China & US market access? ⏰ Our team will present this webinar on Tuesday, May 28, 2024, | 11:00 am to12:00 pm EST 😊 Free Registration: https://lnkd.in/eUEyAhQ9 🔍 Join our webinar to gain insights into the evolving regulatory landscape for Software as a Medical Device (SaMD) products in both the China NMPA and the U.S. FDA. As digital health technologies continue to advance, SaMD has emerged as a significant sector in the medical device industry. In the U.S., the FDA has been actively developing a regulatory framework to ensure the safety and effectiveness of SaMD, while in China, the NMPA is also making strides in establishing regulations that align with its unique healthcare ecosystem. 📝 Our expert speakers will delve into the key requirements, processes, and approval criteria for SaMD products in these two largest MedTech markets in the world, providing you with a comprehensive understanding of the nuances and complexities involved in navigating these regulatory environments. After this 60-minute webinar, you will have a practical understanding of the following areas about SaMD registration in China NMPA and US FDA： • General regulatory landscape of SaMD • SaMD Key Regulations and Standards • Specific SaMD classification and naming rules • General of Requirements of SaMD Registration • Clinical Evaluation Requirements #Chinamarket #USmarket #regulatoryaffairs #NMPA #FDA #medicaldevice #SaMD #registration #clinicalevaluation #classification #standards #regulations

🌟 Exciting Breakthrough in UK Healthcare! The MHRA unveils a revolutionary system to deliver life-saving medicines with unprecedented speed by changing the approvals game. Here's what you need to know: 🚀 It's live: The International Recognition Procedure (IRP) launched on January 1st, 2024. 🔍 Timelines are being condensed: Approval times are down from 150 days on average to a targeted 60-110 days. 🌏 Worldwide collaboration: Working with international regulatory bodies like those in the US, Canada, and Japan, new medicine approvals will be expedited. Explore further with links 🔗 to sources in the comments below ⬇️ #mhra #IRP #healthcarenews

Business Plan 2024/25 Medicines and Healthcare products Regulatory Agency #UK Keeping patients safe and enabling access to high quality, safe and effective medical products 2.1.4 Deliver the 2024/25 milestones for medical devices international recognition in our roadmap of activity, working in parallel on approaches to maintain the UKCA as an #attractive #route for 🔝🔝 #innovators.🔝🔝 ➡➡ 2.4.3 Facilitate an international workshop of antimicrobial resistance (#AMR) innovators and stakeholders to identify approaches to accelerate patient access to novel anti-microbial products by end Q4. ⬅⬅ 2.2 ➡➡Deliver #innovative pathways ⬅⬅for access to transformative medicines and medical devices in co-ordination with #healthtechnologyassessment and #healthservicebodies.  We will be introducing ➡➡ #new risk proportionate regulatory approaches to ensure that the UK remains at the forefront of medical and scientific discovery and is an attractive environment in which to develop novel and innovative medical products. ⬅⬅ We will continue to involve patients in ➡➡ #our benefit risk decisions and in communicating the best advice on how to use medical products safely and effectively. ⬅⬅ European Commission 😪😪😪😴😴😴

📢 Health Canada (27-Feb) - Are you aware of the Regulatory enrolment process (REP) in Canada requiring manufacturers to use electronic template for their submission? Health Canada's Regulatory Enrolment Process (REP) introduces a streamlined method for the submission and processing of regulatory information across various product lines, including medical devices. The REP utilizes web-based templates, transitioning towards a unified submission intake and enabling the automation of regulatory transaction imports. For medical devices, the current template version 2.0.0 will be updated to version 3.0.0 in July 2024, with mandatory adoption 18 months post-launch. This move aims to enhance the efficiency of regulatory activities, supporting smoother interactions between Health Canada and medical device stakeholders. For detailed information, visit Health Canada's REP page: "Regulatory enrolment process (REP) - Canada.ca". For any question or support, contact me at alexandre.petiard@lexqara.com